Resurgence in the Use of Physiologically-based Pharmacokinetic Models in Pediatric Clinical Pharmacology: Parallel Shift in Incorporating the Knowledge of Biological Elements and Increased Applicability to Drug Development and Clinical Practice Publication Resurgence in the Use of Physiologically-based Pharmacokinetic Models in Pediatric Clinical Pharmacology: Parallel Shift in Incorporating the Knowledge of Biological Elements and Increased Applicability to Drug Development and Clinical Practice This study had two primary aims: (i) To describe an example of the development work…CertaraMarch 1, 2011
Why are PK Parameters Lognormally Distributed? Knowledge Base Why are PK Parameters Lognormally Distributed? The statistical analysis of pharmacokinetic parameters is often overlooked and not always well understood. The…CertaraFebruary 10, 2011
What are Direct and Indirect Pharmacodynamic Models? Knowledge Base What are Direct and Indirect Pharmacodynamic Models? When constructing pharmacodynamic (PD) models, you will often encounter the adjectives “direct” and “indirect” describing…CertaraFebruary 8, 2011
What is Modeling and Simulation? Knowledge Base What is Modeling and Simulation? I am currently attending a short conference on modeling and simulation in pediatric clinical pharmacology,…CertaraFebruary 1, 2011
Physiologically-based Pharmacokinetic Model for Topotecan in Mice Publication Physiologically-based Pharmacokinetic Model for Topotecan in Mice Topotecan is a chemotherapeutic agent of choice for the second-line treatment of recurrent ovarian cancer.…CertaraFebruary 1, 2011
Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by Use of a Stable Isotope in Patients with Epilepsy Publication Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by Use of a Stable Isotope in Patients with Epilepsy The anticonvulsant properties of phenytoin (PHT) were discovered in 1938. Since then, it has been…CertaraFebruary 1, 2011
Poor Correlation between Urinary Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by a Stable Isotope Method in Epilepsy Patients Publication Poor Correlation between Urinary Excretion of the Principal Urinary Metabolites of Phenytoin and Absolute Oral Bioavailability Determined by a Stable Isotope Method in Epilepsy Patients The anticonvulsant properties of phenytoin (PHT) were discovered in 1938. Since then, it has been…CertaraFebruary 1, 2011
Physiologically-based Pharmacokinetics in Drug Development and Regulatory Science Publication Physiologically-based Pharmacokinetics in Drug Development and Regulatory Science The application of physiologically-based pharmacokinetic (PBPK) modeling is coming of age in drug development and…CertaraFebruary 1, 2011
Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism Publication Unexpected Effect of Rifampin on the Pharmacokinetics of Linezolid: In Silico and In Vitro Approaches to Explain Its Mechanism The effect of rifampin on the steady-state pharmacokinetics of linezolid was evaluated in an open-label,…CertaraFebruary 1, 2011
Critique of the Two-fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-drug Interactions Publication Critique of the Two-fold Measure of Prediction Success for Ratios: Application for the Assessment of Drug-drug Interactions Current assessment of drug-drug interaction (DDI) prediction success is based on whether predictions fall within a two-fold range of the observed data. This strategy…CertaraFebruary 1, 2011